RecruitingPhase 4NCT06236022

The Effects of Sirolimus in Patients With Dilated Cardiomyopathy Infected With Kaposi Sarcoma-associated Virus

Sponsor

Tongji Hospital

Enrollment

276 participants

Start Date

Jan 1, 2024

Study Type

INTERVENTIONAL

Conditions

Dilated Cardiomyopathy Kaposi's Sarcoma-Associated Herpesvirus Infection

Summary

Evaluating the efficacy of sirolimus (compared to standard therapy alone) in the treatment of dilated cardiomyopathy infected with Kaposi Sarcoma-associated virus -- a multicenter randomized controlled study.

Eligibility

Min Age: 18 YearsMax Age: 70 Years

Inclusion Criteria4

to 70 years of age;
Diagnosed as dilated cardiomyopathy. Specifically, (i) left ventricular ejection fraction \<45% (\>2 SD) and/or fractional shortening \<25% (\>2 SD), as ascertained by echocardiography, radionuclide scanning, or cardiac magnetic resonance imaging; (ii) left ventricular end-diastolic diameter \>117% of the predicted value corrected for age and body surface area (Henry's formula), which corresponds to 2 SD of the predicted normal limit +5%; and (iii) In the absence of severe coronary artery disease or valvular disease.
KSHV DNA seropositivity;
Patients are voluntary and signed informed consent.

Exclusion Criteria7

Allergic to rapamycin or its derivatives；
The proportion of neutrophils less than 0.5\*10\^9/L or platelet less than 2.5\*10\^10/L;
Pregnant women or plan to;
Participate in any drug clinical trials within 3 months;
Serious neurological disease (Alzheimer's disease, Parkinson syndrome, progressive lower limbs or deaf patients);
Previous history of cancer or tumor, or pathological examination confirmed precancerous lesions;
Patients were not optimally managed.